Trial record 1 of 1 for:    px-478
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Phase I Trial of PX-478

This study has been completed.
Sponsor:
Information provided by:
Oncothyreon Inc.
ClinicalTrials.gov Identifier:
NCT00522652
First received: August 28, 2007
Last updated: May 14, 2010
Last verified: May 2010
  Purpose

This study is being conducted to determine the safety and biologic activity of PX-478, and to allow for observation of any preliminary evidence of antitumor activity in patients with advanced metastatic cancer.


Condition Intervention Phase
Advanced Solid Tumors
Lymphoma
Drug: PX-478
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Trial of Oral PX-478 (a HIF-1α Inhibitor) in Patients With Advanced Solid Tumors or Lymphoma

Resource links provided by NLM:


Further study details as provided by Oncothyreon Inc.:

Primary Outcome Measures:
  • To determine the MTD of PX-478 administered orally on days one to five of a 21 day cycle [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the safety profile of PX-478 when administered orally on days one to five of a 21 day cycle [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
  • To evaluate pharmacodynamic measures of the effects of PX 478 on the HIF 1-alpha pathway, and related tumor markers [ Time Frame: 42 days ] [ Designated as safety issue: No ]
  • To determine the PK profile of PX 478 when administered orally on days one to five of a 21 day cycle [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • To evaluate the effects of PX 478 on tumor blood flow and vascular permeability as measured by DCE MRI [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • To evaluate the anti-tumor activity of PX 478 in patients with advanced malignancies [ Time Frame: 42 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: August 2007
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Investigational Drug
Dose Escalation
Drug: PX-478
Oral formulation, dose escalation, taken on days 1 to 5 of a 21 day cycle until progression or development of unacceptable toxicity

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient has signed the informed consent and must be considered legally capable of providing his or her own consent for participation in this study.
  • The patient has a histologically or cytologically confirmed diagnosis of advanced solid tumor or lymphoma and has failed or is intolerant of standard therapy.
  • The patient is ≥18 years of age.
  • ECOG performance status 0 to 1.
  • The patient has a predicted life expectancy of at least 12 weeks.
  • Patients must have discontinued prior chemotherapy or other investigational agents for at least three weeks prior to receiving the first dose of study drug (six weeks for mitomycin C, nitrosureas, vaccines, or antibody therapy) and recovered from the toxic effects of that treatment (recovered to baseline or ≤Common Toxicity Criteria for Adverse Events (CTCAE) grade 1).
  • Patients must have discontinued any radiation therapy at least four weeks prior to entry into the study and have recovered from all radiation-related toxicities (recovered to baseline or ≤CTCAE grade 1).
  • The patient has adequate hematologic function defined as: WBC count >3,000 cells/μL; platelets >100,000/μL; hemoglobin >9 g/dL (may be transfused to this level); ANC >1500 cells/μL.
  • The patient has adequate hepatic function defined as: bilirubin <1.5 mg/dL; aspartate aminotransaminase (AST/SGOT) & alanine aminotransferase (ALT/SGPT) <2.5 x ULN or <5 x ULN if due to metastatic disease.
  • The patient has adequate renal function as defined by serum creatinine level <1.5 mg/dL.
  • Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method; abstinence) prior to study entry and for the duration of study participation. The patient, if a man, agrees to use effective contraception or abstinence.

Exclusion Criteria:

  • Patients with any active infection requiring i.v. antibiotics at study entry.
  • Any serious concomitant systemic disorders that in the opinion of the investigator would place the patient at excessive or unacceptable risk of toxicity.
  • Surgery within the four weeks prior to the first dose of PX 478.
  • Significant central nervous system (CNS) or psychiatric disorder(s) that preclude the ability of the patient to provide informed consent.
  • Known or suspected brain metastases that have not received adequate therapy. In the case of previously treated brain metastases, a minimum of four weeks interval between completion of radiation therapy and registration on study with radiologic evidence of stable or responding brain metastases is required. In the setting of previous CNS metastasectomy, adequate (minimum four week) recovery from surgery and/or radiation therapy should be documented.
  • Patients with a history of seizures, non-healing wounds, or arterial thrombosis.
  • Patients with unstable atrial or ventricular arrhythmias requiring control by medication; any cardiac ischemic event experienced within the preceding six months; prior history of congestive heart failure requiring therapy.
  • Patients who are breastfeeding or pregnant (confirmed by serum β-HCG within 10 days prior to the start of study treatment if applicable).
  • Patients with total gastrectomy or partial bowel obstruction.
  • Any condition that could jeopardize the safety of the patient and compliance with the protocol.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00522652

Locations
United States, Arizona
TGen Clinical Research Services at Scottsdale Healthcare
Scottsdale, Arizona, United States, 85258
United States, Texas
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Oncothyreon Inc.
  More Information

No publications provided by Oncothyreon Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Larry Romel / Sr. Director, Clinical Operations, Oncothyreon Inc
ClinicalTrials.gov Identifier: NCT00522652     History of Changes
Other Study ID Numbers: PX-478-001
Study First Received: August 28, 2007
Last Updated: May 14, 2010
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Oncothyreon Inc.:
cancer
advanced cancer
lymphoma

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 24, 2014